Triamcinolone Acetonide

ANDA 40467, held by Fougera Pharms. Triamcinolone Acetonide.

As of Nov 15, 2026, ANDA 40467 (Triamcinolone Acetonide), held by Fougera Pharms, was first approved by FDA on Apr 21, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 21, 2003
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 21, 2003	Original application	Approved	None posted

Products

2 strengths and forms


Triamcinolone Acetonide0.025% · lotion;topical	Triamcinolone Acetonide	Rx
Triamcinolone Acetonide0.1% · lotion;topical	Triamcinolone Acetonide	Rx

All 2 submissions, including labeling and manufacturing supplements


May 14, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Apr 21, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40467
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters